Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 08922efa-5a90-4dfb-b9f4-a6c4f8dba3c9
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.005 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Cetyl Alcohol Cocamidopropyl Betaine Coconut Acid Distearyl Phthalamic Acid Ethylhexylglycerin Glycerin Hydrogenated Polybutene (1300 Mw) Lauric Acid Lauryl Glucoside Myristic Acid Phenoxyethanol Phytosteryl/octyldodecyl Lauroyl Glutamate Potassium Cocoate Potassium Cocoyl Glycinate Potassium Hydroxide Propanediol Propylene Glycol D&c Red No. 33 Sodium Chloride Sodium Cocoyl Isethionate Sodium Isethionate Sulfur Titanium Dioxide Tocopherol D&c Violet No. 2 Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-10

Description

Salicylic Acid 0.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid 0.5%

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

Section 50565-1

Keep out of reach of children. If swallowed get medical help right away.

Warnings

For external use only

Directions

Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 30-60 seconds, avoiding all contact with eyes. Rinse thoroughly; pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Questions?

1-888-995-5656

Active Ingredient

Salicylic Acid 0.5%

Inactive Ingredients

Water/Aqua/Eau, Cocamidopropyl Betaine, Potassium Cocoyl Glycinate, Glycerin, Sodium Cocoyl lsethionate, Lauryl Glucoside, Colloidal Sulfur, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Fragrance/Parfum, Sodium lsethionate, Xanthan Gum, Tocopherol, Coconut Acid, Lauric Acid, Potassium Hydroxide, Sodium Chloride, Ethylhexylglycerin, Propylene Glycol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).

Stop and Ask A Doctor
  • If skin irritation occurs or gets worse.
When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in eyes.
Principal Display Panel – 125 Ml Tube Label

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

Principal Display Panel – 125 Ml Carton Label

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

RODAN+FIELDS

125 mL/4.2 Fl. Oz. U.S.


Structured Label Content

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help right away.

Purpose

Acne treatment

Warnings

For external use only

Directions

Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 30-60 seconds, avoiding all contact with eyes. Rinse thoroughly; pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Questions?

1-888-995-5656

Active Ingredient (Active ingredient)

Salicylic Acid 0.5%

Inactive Ingredients

Water/Aqua/Eau, Cocamidopropyl Betaine, Potassium Cocoyl Glycinate, Glycerin, Sodium Cocoyl lsethionate, Lauryl Glucoside, Colloidal Sulfur, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Fragrance/Parfum, Sodium lsethionate, Xanthan Gum, Tocopherol, Coconut Acid, Lauric Acid, Potassium Hydroxide, Sodium Chloride, Ethylhexylglycerin, Propylene Glycol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Titanium Dioxide (Cl 77891), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).

Stop and Ask A Doctor (Stop and ask a doctor)
  • If skin irritation occurs or gets worse.
When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Rinse right away with water if it gets in eyes.
Principal Display Panel – 125 Ml Tube Label (Principal Display Panel – 125 mL Tube Label)

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

Principal Display Panel – 125 Ml Carton Label (Principal Display Panel – 125 mL Carton Label)

RODAN+FIELDS

UNBLEMISH

1

Refining Acne

Wash

RODAN+FIELDS

125 mL/4.2 Fl. Oz. U.S.


Advanced Ingredient Data


Raw Label Data

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